HIV Prevention Research Study
Researchers at The Fenway Institute are investigating an experimental drug to prevent HIV.
Eligibility Criteria
Cisgender Women Ages 18+
Have been sexually active with a cisgender man (condomless) in last 12 months
Study Information
Compensation Provided
Conducted in
Boston, MA
Study Background
Researchers at The Fenway Institute are investigating an experimental drug to prevent HIV.
Study Background
Researchers at The Fenway Institute are investigating an experimental drug to prevent HIV.
Additional Information
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Cisgender women, 18 years of age or older
- At least 1 episode of condomless vaginal or anal sex with a cisgender man in the last 12 months
- Presumed HBV negative or known HBV surface antigen (HBVsAg) negative
- Speak English
- Negative for HIV (will be tested to confirm)
If you participate in this study, you will participate in 13 various study visits across a 2.5 year span. Details of these visits are outlined below:
Screening Visit: Before starting the study, you’ll have a screening visit to check if you’re eligible. This visit isn’t counted in the 130 weeks.
First Phase (Randomized Phase): You’ll visit the clinic at least 6 times during this phase, which lasts about a year. At each visit, you’ll provide updated medical history, get HIV risk-reduction counseling, have a brief physical exam, measure vital signs, and give blood and/or urine samples. If you’re in the LEN group, you may also receive phone calls after each injection visit.
Second Phase (PK Tail Phase): After the Randomized Phase, you’ll move into the PK Tail Phase, which lasts about 1.5 years. You’ll visit the clinic up to 7 times during this period. Regardless of what you were assigned in the first phase, both groups will recieve F/TDF during this phase.
Early Study Drug Discontinuation (ESDD) Visit: If you stop the study drug during either phase for reasons other than getting HIV, you’ll have an ESDD visit within 3 days after stopping the drug. If you choose not to proceed to the PK Tail Phase after stopping LEN, you’ll have an ESDD visit about 6 months after your last injection or within 3 days after stopping the drug.
30-Day Follow-up Visit: If you decide to discontinue the study drug during the PK Tail Phase, you’ll also have a 30-day follow-up visit.
Conclusion of Study: When the study ends, you’ll be referred to local HIV prevention services for continued care and support. Throughout the entire study period, you’ll have a total of at least 13 clinic visits and regular check-ins with the study team to ensure your safety and well-being.
You will be reimbursed between $650 and $700 for completing 13 visits in this 2.5 year-long study. This money is meant to help pay for things like your time and effort for each scheduled study visit.
You will receive $75 for study visits with injection, and $50 for all other required study visits.
You will receive $50 for any extra study visits required if you stop the study early, if you acquire HIV, or if there are any other unscheduled visits needed.
At study visits where a blood draw is needed for pharmacokinetics (how the body processes the drug), which requires you to wait 4 hours after you receive the trial drug (Injection1/Day 1), you will also receive meal voucher (e.g., for DoorDash to order food) because of the longer visit time.
Reasonable travel expenses (including parking in the area for the time of the visits +30 minutes before and after visits and ridesharing compensation for up to 15 mile radius from our site) for trial related visits may be covered.
There is no cost for you to participate in our research study.
